BEUDAMED
    FDA Registration Active 🇨🇳 China

    Disposable Sterile Syringe, Disposable Sterile Insulin Syringe, Disposable Sterile Injection Needles

    Reg #: 3013496867 · FEI: 3013496867 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD
    Registration Number
    3013496867
    FEI Number
    3013496867
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    South Fanlou Road, Shan County Development Zone
    City
    Heze Shandong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K212033

    Owner / Operator

    Firm Name
    Shandong Zhushi Pharmaceutical Group Co., Ltd
    Operator Number
    10052646
    Address
    South Fanlou Road, Shan County Development Zone
    City
    Heze
    State
    Shandong
    Postal Code
    274300
    Country
    CN
    Correspondent
    Kunfu Zhu

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI
    Syringe, Piston FMF

    Proprietary Names

    Disposable Sterile Syringe, Disposable Sterile Insulin Syringe, Disposable Sterile Injection Needles

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device